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Details for New Drug Application (NDA): 021127
The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 021127
Tradename: | OPTIVAR |
Applicant: | Mylan Speciality Lp |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Therapeutic Class: | Ophthalmic Agents Respiratory Tract Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021127
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127 | NDA AUTHORIZED GENERIC | Wallace Pharmaceuticals Inc. | 51525-7815 | E | 51525-7815-6 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | May 22, 2000 | TE: | RLD: | Yes |
Expired US Patents for NDA 021127
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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